FDA Approvals

WEDNESDAY, Feb. 14, 2018 -- The first blood test designed to help doctors evaluate whether a suspected brain injury is a concussion has been approved by the U.S. Food and Drug Administration.

Traditional concussion evaluation includes a CT scan of the head to detect any brain tissue damage. But many people who have such a scan do not have brain lesions that are detectable, the FDA said Wednesday in a news release.

WEDNESDAY, Feb. 14, 2018 -- Erleada (apalutamide) has been approved by the U.S. Food and Drug Administration to treat non-spreading prostate cancer that continues to grow despite hormone therapy.

Prostate cancer is the second-most-common form of the disease among men in the United States, the National Cancer Institute says. More than 161,000 men were diagnosed in 2017, and nearly 27,000 men were projected to die of prostate cancer last year, the NCI estimates.

FRIDAY, Jan. 26, 2018 -- Lutathera (lutetium Lu 177 dotatate) is the first radioactive drug to be approved by the U.S. Food and Drug Administration to treat certain cancers of the gastrointestinal tract and pancreas, the agency said Friday in a news release.

About 1 in 27,000 people is diagnosed annually with this type of cancer, called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In addition to the pancreas, the cancer also may emerge in the stomach, intestines, colon and rectum, the FDA said.

FRIDAY, Jan. 12, 2018 -- Lynparza (olaparib) has been approved by the U.S. Food and Drug Administration to treat spreading breast cancer caused by a BRCA gene mutation.

The drug is among a class called poly ADP-ribose polymerase (PARP) inhibitors, which are designed to block an enzyme involved in repairing damaged DNA. The hope is that by blocking the repair of cancer cells, the cells will die and slow or stop tumor growth, the FDA said in a news release Friday.

TUESDAY, Dec. 19, 2017 -- Luxturna, a form of gene therapy, has been approved to treat a rare group of inherited vision disorders that can lead to blindness.

The disorders are broadly grouped together and known as biallelic RPE65 mutation-associated retinal dystrophy. They affect a combined 1,000 to 2,000 people in the United States, the U.S. Food and Drug Administration said Tuesday in a news release.

TUESDAY, Dec. 12, 2017 -- Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first remedy to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to inflammation of the blood vessels.

Other symptoms of the condition, formerly called Churg-Stress syndrome, include asthma and an overabundance of an infection-fighting white blood cell called an eosinophil. The inflamed blood vessels may affect the lungs, intestines, skin, heart and nervous system.

MONDAY, Dec. 11, 2017 -- Admelog (insulin lispro), a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat people with either type of diabetes, for patients aged three years and older.

It's the first drug approved as a "follow-up" product based on an abbreviated new process dubbed 505(b)(2), the agency said Monday in a news release.

FRIDAY, Dec. 1, 2017 -- Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as the nation's first biosimilar drug to treat certain breast and stomach cancers, the agency said Friday in a news release.

The maker of a biosimilar, derived from a living organism, must demonstrate that the new product is "highly similar" to an already approved medication, and that it has no clinically significant difference in terms of its potency, safety and purity, the FDA said.

FRIDAY, Dec. 1, 2017 -- Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.

Opioid abuse is diagnosed when a person's pattern of opioid use leads to "significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose," or opioids are taken in far higher-than-recommended doses, the agency said in a news release.